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Qingkailing Injection Versus Puerarin Injection on Withdrawal Rate of Corticosteroids in Patients With Active Rheumatoid Arthritis

C

Chengdu PLA General Hospital

Status

Unknown

Conditions

Rheumatoid Arthritis

Treatments

Drug: Qingkailing injection 40 ml
Drug: Puerarin injection 400 mg

Study type

Interventional

Funder types

Other

Identifiers

NCT02264301
QKL20140588

Details and patient eligibility

About

The purpose of this study is to evaluate the effect of Qingkailing injection versus Puerarin injection on withdrawal rate of corticosteroids in patients with active rheumatoid arthritis.

Enrollment

150 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • with active RA
  • without taking any other medication for the treatment of active RA in at least 4 last weeks
  • aged from 18 to 75 years
  • without conflict to the written, informed consent signed prior to the enrollment.

Exclusion criteria

  • being included in other clinical trial within the last 4 weeks
  • with abnormal liver or kidney function (more than 1 time above the high normal)
  • with serious cardiovascular disease
  • with hematologic disease
  • being in pregnancy, lactation period or under a pregnancy plan
  • with severe gastrointestinal disease
  • with contraindication or being allergic to the test drugs
  • being under the treatment of drugs within 1 previous week, that might affect the results of the trial, such as non-steroidal anti-inflammatory drugs, steroidal anti-inflammatory drugs, immunosuppressants, anti-ulcer drugs
  • being not compatible for the trial medication, or other circumstances at the discretion of investigators
  • without legal capacity or only with limited legal capacity.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

150 participants in 2 patient groups

Puerarin injection 400 mg
Active Comparator group
Description:
Patients under the treatment of Puerarin injection 400 mg,daily,for 24 weeks
Treatment:
Drug: Puerarin injection 400 mg
Qingkailing injection 40 ml
Experimental group
Description:
Patients under the treatment of Qingkailing injection 40 ml,daily,for 24 weeks
Treatment:
Drug: Qingkailing injection 40 ml

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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